ASSOCIATE SPECIALIST JOB DESCRIPTION

An Associate Specialist handles work that most laboratory and quality teams cannot absorb into existing roles. The title covers a narrow but consequential band of technical ownership: specimen integrity, ingredient safety evaluation, or packaging acceptability, depending on where in the organization the seat sits. In pharmaceutical and life sciences settings, this means operating within regulatory frameworks such as GMP and GxP, or advancing Next Generation Risk Assessment approaches that inform product approval decisions. Thin technical coverage here surfaces in audit findings, batch release delays, or gaps in safety data that reach regulators.

As the Associate Specialist, you own a defined technical domain within a pharmaceutical or life sciences R&D or quality function, contributing directly to the integrity of safety evaluations, specimen workflows, or packaging release decisions that support compliant product development. You operate within a specialized team, coordinating with CROs, program managers, or supplier quality groups, and your output feeds directly into regulatory submissions or manufacturing operations.

Career Impact: Gaining hands-on experience with GMP compliance, LIMS systems, or New Approach Methodologies at this level builds a technical profile that translates directly to senior specialist and scientist tracks in pharmaceutical and biotech hiring markets.

Business Impact: When packaging batches are released correctly, sample inventories are accurate, and safety data meets regulatory standards, the product development pipeline moves without costly holds - this role's daily output protects that continuity.

Growth Opportunity: The scope of this seat, spanning vendor coordination, CRO management, and regulatory documentation, positions experienced holders to move into Associate Research Scientist, Quality Engineer, or program management roles within three to five years.

• Evaluate incoming materials or specimens against acceptance criteria, documenting findings contemporaneously to support batch release or safety decisions.
• Coordinate sample inventory, shipping logistics, and disposition tracking with CROs and internal teams to maintain uninterrupted specimen availability.
• Contribute to the integration of risk assessment methodologies, including in vitro and in silico approaches, into established safety evaluation processes.
• Lead or participate in continuous improvement activities, root cause investigations, and defect identification to strengthen quality systems.
• Manage and maintain compliance documentation including SOPs, laboratory records, and metadata in accordance with GLP and GCP requirements.
• Partner with external organizations including vendors, academia, and regulatory working groups to advance technical standards and resolve material or data issues.
• Review and interpret results from external testing activities, translating findings into actionable recommendations for program or quality leadership.

• Bachelor's degree in Natural Sciences, Biology, Chemistry, or a related field, or equivalent work experience.
• 2 or more years of experience in a pharmaceutical, biotech, or life sciences laboratory environment, with direct exposure to quality or research operations.
• Working knowledge of Good Manufacturing Practices (GMP) or Good Laboratory Practice (GLP) requirements applicable to drug substance or drug product development.
• Demonstrated ability to manage sample tracking, specimen handling, or materials coordination with high attention to detail and data accuracy.
• Experience contributing to safety assessments, quality investigations, or regulatory documentation within a cross-functional team setting.
• Strong written and oral communication skills with the ability to correspond professionally with internal stakeholders and external contacts.
• Ability to adapt to shifting priorities, manage concurrent workstreams, and escalate issues appropriately within a structured program environment.

• Advanced degree (Master's or PhD) in Toxicology, Natural Sciences, or a closely related discipline with exposure to Next Generation Risk Assessment or PBPK modeling approaches.
• Prior experience in a Contract Research Organization (CRO) environment or in coordinating externally managed studies, including shipping manifests and vendor communications.
• Familiarity with regulatory toxicology frameworks and the application of alternative testing methods to chemical or ingredient safety evaluations.
• Experience supporting or participating in LIMS buildout, system validation, or laboratory information management configuration projects.

• Batch release accuracy rate, measuring the proportion of reviewed materials correctly cleared or rejected without rework.
• Sample inventory variance, reflecting how closely projected specimen availability matches actual stock at each reporting interval.
• Documentation compliance rate, tracking the percentage of GLP or GCP records completed without audit findings or corrective actions.
• External activity turnaround, measuring elapsed time between CRO study initiation and results integration into internal safety or quality systems.
• Defect identification rate per inspection cycle, indicating thoroughness of incoming material review against specification.
• Typical tools: laboratory information management systems (commonly LIMS platforms); quality and ERP systems (commonly SAP-based environments).

• Base Salary Range: $55,000 to $80,000 annually, depending on seniority and specialization.
• Bonus: 5% to 10% annual performance bonus typical in pharmaceutical settings.
• Equity: Equity uncommon at this level; stock purchase plans available at larger employers.
• Health Benefits: Medical, dental, and vision coverage; employer contribution standard.
• PTO: 15 to 20 days annually plus standard federal holidays.
• Common Perks: Tuition reimbursement, professional development funding, and lab certification support.

Figures are estimates based on general US market benchmarks and may be outdated. Adjust based on location, company size, and seniority level.

Reasonable accommodations are available to applicants and employees with disabilities throughout the hiring process and employment, in compliance with the Americans with Disabilities Act. All qualified applicants will be considered without regard to race, color, religion, sex, national origin, age, genetic information, veteran status, or any other characteristic protected under applicable federal, state, or local law. Employment is contingent on successful completion of a background check. Candidates must hold current authorization to work in the United States without sponsorship requirement, unless otherwise specified.

The Associate Specialist in New Approach Methodologies owns the development of research and testing strategies that integrate NAMs into product and ingredient safety evaluations across Nestle R&D projects from inception through all stages of development. Working alongside CROs, academia, and industry partners, this role shapes chemical safety-based decision making and advances food risk assessment through expert groups and cross-sector networks.

Key Responsibilities

• Evaluate safety of novel products and ingredients to support the 'safety by design' approach in R&D projects.
• Contribute to and advise on the integration of New Approach Methodologies (NAMs, e.g. ADME and PBPK modeling) and Next Generation Risk Assessment (NGRA) approaches in the safety by design process.
• Lead research on the applicability of NAMs to the safety assessment of new ingredients, including planning, management, and results interpretation of external activities with CROs, academia, and industries.
• Develop strategies to assess the feasibility and integration of NAMs and NGRA into food safety and risk assessment, integrating in vitro/in silico/in vivo toxicology results.
• Develop tools and data in the domain of food risk assessment through research projects and contributions to expert groups.
• Participate in internal and external expert networks and projects to promote cross-fertilization between industry, academia, CROs, and other relevant entities.
• Coach and guide colleagues and younger project team members in the area of expertise.

Required Qualifications

• Master's degree or PhD in Natural Sciences or a related field with a link to New Approach Methodologies.
• Strong experience and exposure to NAMs, preferably hands-on experience with tools for ADME and PBPK modeling and NGRA approaches; some experience in medicinal chemistry and/or pharmaceutical product development is a plus.
• Knowledge in toxicology and standard risk assessment of chemicals, including basics in regulatory toxicology.
• Exposure to alternatives to animal testing (in vitro/in silico approaches).
• Strength in written and oral communication, transversal collaboration, cooperation, and networking; agility and openness to change in a fast-evolving field.
• Strong commitment to consumer safety.
• Fluent in English.

Reporting to the Supplier Quality leadership, the Associate Specialist, Supplier Quality leads incoming inspection of packaging materials including vials, stoppers, labels, and cartons to ensure all raw and packaging materials used in drug substance and drug product manufacturing meet acceptability standards. Partnering with vendors, warehouse personnel, and cross-functional teams, this role supports continuous improvement initiatives and maintains compliance with current Good Manufacturing Practices across the packaging inspection unit.

Primary Duties

• Inspect incoming packaging materials including vials, bottles, stoppers, caps, labels, inserts, cartons, etc., and contemporaneously document findings and enter results into LIMS.
• Second check and release batches for use in production.
• Participate in iMEX-related activities including continuous improvement (CI) and daily T1 meetings, and may act as safety, standard work, visual management, CI, or structured Gemba leader.
• Identify defects and participate in associated investigations.
• Participate in calls with vendors and interact with warehouse personnel to assure timely receipt of tailgate samples.
• Participate in unit-level continuous improvement projects and community service projects such as calibration tracking, notebook filing, and SOP revision.
• Complete training and annual performance activities promptly.

Education & Experience

• Associate's degree with four years of relevant experience, a Bachelor's degree with 0–2 years of experience, or six years of relevant experience without a degree.
• Experience in the pharmaceutical industry and in quality-administered systems.
• Sound knowledge of current Good Manufacturing Practices (part of GxP).
• Computer skills including experience with gLIMS, QTS, SAP, and AMEX lab tools are desired.
• Ability to work effectively in team environments within own team and across interdepartmental teams.
• Effective written and oral communication skills.

Sitting at the intersection of product calendar governance and cross-functional process management, the Associate Specialist, Product Operations builds and maintains annual, seasonal, and close-to-market calendars that align Category Management, Merchandising, and Design teams across all markets and channels. Operating across Planning, Marketing, and Product Development functions, this role delivers milestone tracking, root cause analysis, and process standardization that enable on-time product launches at Crocs.

Duties

• Manage and maintain the annual, seasonal, and close-to-market calendars for the Product and Merchandising teams.
• Drive execution of key product milestones by documenting deliverables, owners, and templates.
• Partner with Planning, Marketing, and Product Development teams to build a rolling twelve-month calendar view that avoids cross-functional conflicts.
• Track progress against milestones and report on-time delivery to functional leaders.
• Conduct milestone hindsights to find improvement opportunities and perform root cause analysis when objectives are missed.
• Serve as the Product Operations liaison for Planning and Marketing Ops.

Skills & Qualifications

• Bachelor's degree in a related field or equivalent experience.
• Proven ability to manage calendars and projects with strong organizational, analytical, and process-building skills.
• Ability to work effectively in a fast-paced environment and keep others on track for deliverables and deadlines.
• Adjusts quickly to changing priorities and conditions, coping effectively with complexity and change.
• Exceptional oral and written communication skills with strong time management and sense of urgency.

Embedded within the TD team, the Associate Specialist delivers day-to-day coordination of commercial human tissue and peripheral sample management, tracking, and inventory across LIMS systems including active participation in RWC LIMS buildout and modifications. Working closely with the Program Manager and CROs, this role ensures sample integrity, metadata accuracy, and timely shipping logistics that keep research operations running without interruption.

Core Functions

• Commercial human tissue and peripheral sample management and tracking in the LIMS system.
• Play an integral part in the RWC LIMS buildout and modifications.
• Take active part in LIMS buildout discussions with the working group.
• Track, coordinate, and manage samples on a day-to-day basis for the TD team, including contribution to quarterly dashboard updates on sample disposition.
• Work closely with the Program Manager on sample inventory, shipping to CROs including inventory/shipping manifests, internal coordination, sample receiving, and escalating sample-related issues in a timely manner.
• Provide periodic projections on sample inventory and manage timelines for sample delivery and shipping.
• Manage and track patient metadata, escalating any issues to the Program Manager.
• Maintain the sample storage room with oversight from the Program Manager.

Qualifications & Experience

• Undergraduate degree in biology or a related area mandatory.
• Minimum 1–2 years of LIMS training and experience, preferably in a laboratory setting, mandatory.
• Experience as a human biospecimen sample coordinator, including patient metadata entry, review, tracking, and previous experience with sample management.
• Basic experience in laboratory handling of human tissue samples, especially FFPE tissue blocks.
• Previous experience with Microsoft Office and Microsoft Project is desirable.
• Strong analytical mindset with critical thinking and problem-solving skills; highly adaptable with strong time management skills and excellent attention to detail.
• Able to correspond with internal and external contacts in a professional manner.
• Complete onboarding, relevant tutorials, and/or training as appropriate and required

A key member of the university research community, the Associate Specialist leads execution within a narrowly defined area of specialization, contributing technical expertise to the planning of research projects, consenting participants per IRB requirements, and procuring specimen or tissue collection in compliance with GLP and GCP standards. Collaborating across industry organizations, state and federal agencies, and university committees, this role advances institutional research capacity through peer-reviewed publication, expert liaison, and active participation in professional societies.

Scope of Work

• Collaborate with research and extension personnel on activities such as consenting participants per IRB requirements, procuring specimen or tissue collection, and maintaining documentation per Good Laboratory Practice and Good Clinical Practice requirements.
• Participate in appropriate professional and technical societies, educational organizations, and research groups.
• Review research proposals, journal manuscripts, and publications related to the area of expertise.
• Maintain liaison and respond to the needs of industry organizations, state and federal agencies, and other external groups on issues related to the area of expertise.
• Participate in activities of committees within the department, college, campus, and other University entities as appropriate.

Position Requirements

• 4–10 years of experience demonstrating expertise, with clinical orthopaedic research experience preferred.
• Authorship in peer-reviewed publications and conference papers, with active dissemination of information and other evidence of expertise.
• Must have the ability to work cooperatively and collegially within a diverse environment.
• Familiarity with university policies and procedures.
• 3–5 references required (contact information only).

Stronger digital acquisition and reduced contact center demand depend on the AVP/Senior Associate Specialist, Digital Product Management, who owns the ATE metric and builds secured lending digital journeys including an onboarding experience with Ecosystems Car Partners across home planning, financing, and auto loan product lines. Based within a cross-functional environment spanning UX, analytics, compliance, and technology, this role delivers platform capabilities and commercial outcomes that measurably improve the end-to-end customer experience.

Key Deliverables

• Deliver the best-in-class home planning and financing customer experience and journey, led by digital innovation, and powered by digital analytics and planning tools.
• Deliver a best-in-class home planning and financing customer experience led by digital innovation and powered by digital analytics and planning tools.
• Embed Managing Through Journey and, in partnership with the Auto Loan team, develop an iconic onboarding journey with Ecosystems Car Partners and drive stickiness.
• Own the ATE metric with secured lending stakeholders to drive higher digital acquisition and deliver cost efficiencies, performance, and distribution capabilities on the digital platform.
• Collaborate with UX/design, marketing, analytics, technology, compliance/legal, operations, and lines of business stakeholders to assess feasibility and deliverability of digital solutions in the secured lending space.
• Support secured lending teams and other functions to develop and implement new or enhanced services, plug functionality gaps, and drive commercial success toward reduction in demand from CCTR and Credit Ops.

Professional Experience

• Minimum 4–8 years of working experience.
• Knowledge of mobile and internet capabilities with previous work experience in this field.
• Passionate about best-in-class digital customer experiences and digital innovation.
• Proven track record of working in high-pressure environments with the ability to drive customer traction and usage.
• Ability to engage and influence senior stakeholders.